TIRFENS
(Fenspiride)




COMPOSITION

A film-coated tablet contains

Active substance: fenspiride hydrochloride 80 mg.

Excipients: microcrystalline cellulose, calcium carmellose, povidone K30, croscarmellose sodium, anhydrous colloidal silicon dioxide, magnesium stearate.

Composition of coating: Opadry II white 85F18422 (partly hydrogenated polyvinyl alcohol, titanium dioxide, macrogol, talc).

THERAPEUTIC INDICATIONS

- Treatment of acute and chronic inflammatory processes of ENT organs and respiratory tract (otitis, sinusitis, rhinitis, rhinopharyngitis, tracheitis, rhinotracheobronchitis, bronchitis).

- As a part of complex therapy of bronchial asthma.

- Seasonal and perennial allergic rhinitis and other respiratory and ENT allergic signs;

- Respiratory events following measles, whooping cough, influenza (coughing, hoarseness, throat irritation).

CONTRAINDICATIONS.

- Hypersensitivity to fenspiride hydrochloride or other components;

- age under 14 years old.

ADVERSE EFFECTS

The frequency parameters for the adverse effects indicated below are determined in the following way: common ( 1/100, < 1/10), uncommon ( 1/10 000, < 1/10), frequency undefined.

Cardiovascular effects: uncommon – moderate tachycardia, its severity decreases if dosage is decreased.

Gastrointestinal effects: common – gastrointestinal disturbances, nausea, epigastrium pains; frequency undefined – diarrhea, vomiting.

Nervous system effects: uncommon – somnolence; not known – dizziness.

Skin effects: uncommon – erythema, rash, urticaria, angioneurotic edema, fixed pigmented erythema; frequency undefined – skin itching.

Other: frequency undefined – asthenia, increased fatigue.

DOSAGE AND ADMINISTRATION

Tirfens is orally administered before the meals, washing down with sufficient amount of fluid.

Adults: one tablet twice a day (in the morning and in the evening).

For more significant effect and/or in acute disease: one tablet 3 times daily (morning, afternoon, evening).

DRUG INTERACTIONS

The interaction of fenspiride and other drugs has not been known. Concomitant use of Tirfens and sedative medicines is not recommended due to potentiation of sedative effect. Tirfens potentiates the sedative effect of antihistamine medicines.

PREGNANCY AND LACTATION

Clinical data proving the ability of fenspiride to cause toxicity or maldevelopment of fetus, if administered during pregnancy, has not been determined. That is why the administration of fenspiride during pregnancy is not recommended, though confirmed pregnancy during the fenspiride administration does not require any abortion. Nowadays reliable data regarding the excretion of fenspiride in breast milk has not been determined. That is why administration of fenspiride in lactating women is not recommended.

MANUFACTURED FORM

Film-coated tablets.

10 tablets in a blister.

2 or 3 blisters with a leaflet in a carton box.

Respiratory system

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